Principal Electrical Engineer

The Principal Electrical Engineer leads and provides expertise in the development,
characterization and testing of control software and hardware in medical devices. They develop complex hardware and systems that include high-voltage and pneumatic controls, motor control, sensors and pump drivers, plasma generation, optimize hardware and system performance, and troubleshoot hardware and system issues. They develop software/firmware algorithms that optimize the therapy delivery, Nitric oxide generation, and pneumatic control for overall hardware and system operation. They formulate rational, data-driven decisions while designing software algorithms and complex electromechanical systems that meet medical product requirements. Develop and validate test methods that ensure compliance with requirements. This position is full-time onsite in Waltham, MA.

Responsibilities:
• Architect electrical subsystems for Nitric oxide generation, gas delivery control, and safety control.
• Develop analog and digital circuits for a complex system that generates nitric oxide
gas, controls gas delivery, includes high voltage generation, current sensors,
pneumatic control, environmental sensors, and gas delivery mechanisms
• Generates and implements software/firmware algorithms in C language including
PID control loops for embedded software control and monitoring of complex
systems, therapy delivery control, Nitric Oxide generation, and pneumatics
• Utilizes technical expertise to contribute to the development of system
architectures for respiratory devices. Uses modeling, hardware-in-the-loop
simulation and actual devices to develop, debug and test complex systems to meet
required performance
• Develops and models complex cross-functional systems
• Performs advanced risk analyses using FMEA and fault tree methods. Works with
other engineering disciplines to develop, implement, and verify system solutions
• Evaluates product performance on an on-going basis and initiates and evaluates
required changes to the design to improve and optimize performance
• Interfaces with internal and external clinicians, physicians and thought leaders to
create innovative products and features
• Ensures adherence to company quality system, product specifications, industry
standards, and quality and regulatory procedures and requirements

• Maintains accurate documentation of concepts, designs, drawings, and processes
through lab notebooks or other methods

Requirements:
• Bachelor or Master’s degree in electrical or computer engineering or related
specialization, and 10+ years of related experience
• Demonstrated experience designing, implementing, tuning and analyzing high
accuracy, multi-sensor control circuits and systems, including high-performance
PID feedback and open-loop controls
• Experience implementing software/firmware control algorithms in C language on
embedded, real-time systems
• Experience with digital and analog electrical circuits
• Proven ability to engage effectively in risk analysis including FMEA
• Demonstrated strength in judgment, decision making, and critical thinking
• Excellent written and verbal communication
• Demonstrated strength in building relationships at all levels of an organization

Preferred Experience:
• PhD. in Electrical or computer engineering or related specialization
• Experience in software-based electromechanical medical device development
• Experience with statistical process control
• Experience with pneumatic systems and related components, particularly flow
controllers
• Experience with ventilators and/or respiratory applications
• Experience with Python, Jupyter, and data acquisition systems
• Experience performing design of experiments
• ISO 14971, IEC 60601, IEC 62304.
• Well-versed in medical product R&D and clinical/regulatory process